Regulatory Science for Engineering Intuitive, Engaging, Safe and Effective Human-Device Interaction
(Ananda Kumar, FDA)
Background: Most of the US population would receive magnetic resonance imaging (MRI) scans during their lifetime. The medical community anticipates three out of the four patients with active implantable medical devices (AIMDs) such as cardiac pacemakers, spinal cord, deep brain stimulators, cochlear implants, and defibrillators need MRI during the lifetime of their devices.
The safety concerns due to the RF-field interactions with the implant include thermal damage to tissue from device heating, device malfunction due to induced voltages on device, un-intended nerve stimulation to the patient.
Research Plan: The project would involve methods to quantify to remedy the adverse effects by transfer function (TF) modeling of the device and measurements. The transfer function modeling of the AIMD characterizes the induced heating, voltage effects due to the incident E-fields from the MR transmit coil. The REU student will be involved in the measurement of TF for assessing induced heating and voltage on the AIMD and would perform data analysis and compare experimental results to computer modeling and simulation results.
This project would finally contribute to the development of regulatory science tool that will provide criteria for MR-Conditionally safe interchangeability of AIMD.
Description of the Laboratory Facility at the FDA/OSEL/DBP: The electromagnetic compatibility (EMC) laboratory at the FDA OSEL is a state-of-the-art facility containing MR RF transmit coils in a Faraday-shielded room as medical implant testing system (MITS) and table-top electric (E) field generators called MITS-TT, transfer function (TF) measurement set up (piecewise - PiX and reciprocity methods). Field measurement equipment with electric (E) and magnetic (H) field probes along with a robotic arm (DASY) for non-interference measurements.
Prerequisites: Engineering course work in electromagnetics, experience in MATLAB.
Dr. Kumar has engineering degrees in biomedical from Mercer University and electrical from Johns Hopkins University and has been working in the field of MRI hardware and MR safety for over 25 years. He has numerous peer-reviewed publications and four US patents. He has mentored a number of undergraduate and graduate students at Johns Hopkins University and at the FDA.